What are the responsibilities and job description for the Mechanical Engineer position at BRIDGEMED SOLUTIONS INC?
BridgeMed Solutions, Inc is seeking a Mechanical Engineer. Training will be provided.
Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization that is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives.
Job Title: Mechanical Engineer
Experience: 1-3 of ME Professional Experience required. Experience in medical device is a plus.
Location: Local candidates only
Job Type: Full Time, 100% In-House
Salary: $20-$28 DOE (Non-Exempt)
Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, Free Lunch Fridays, Professional Development Opportunities
Principal Duties and Responsibilities
- Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO).
- Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments.
- Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions.
- Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards.
- Facilitate root cause investigations for non-conformance issues, implementing corrective actions and driving continuous improvement initiatives.
- Project and client management is a must
Skills and Qualifications
- Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).
- 1-3 of ME Professional Experience required.
- Must have SOLIDWORKS EXPERIENCE
- Proven experience in project coordinating and cross-functional team collaboration.
- Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions.
- Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders.
- Proficient in Microsoft Office
- Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.
Salary : $20 - $28
